Discount best replica watches with low price.

Get quality Replica Watches it from replica watches replica magic now!

HomeAbout UsSubscribeResources & ContentArchives Submissions Reprints & Back IssuesContact UsAdvertising

Past News Items - November 2010

Return to past News items index

In the News

FDA Issues Final Rule on Safety Information During Clinical Trials

GE Salmon: One Step Closer to FDA Approval

Fish Oil Linked to Increased Risk of Colon Cancer in Mice

Scientists Take First Look at Nanopesticide Safety


Released: 11/01/10

FDA Issues Final Rule on Safety Information During Clinical Trials

Late September, the US Food and Drug Administration (FDA) announced new rules for how drug sponsors (manufacturers) must report research findings to the FDA for investigational new drug applications (INDs). According to an FDA press release, these rules are designed to “improve the quality of safety reports and better protect people participating in clinical trails for drugs.” The rules will go into effect March 28, 2011.

The rules aim to amend former regulations set forth in 2003 regarding IND submissions by clarifying definitions, expediting report timeliness when adverse reactions appear (within 15 days), and maintaining consistency with international health definitions and standards.

Currently, because of loose definitions, the FDA receives many INDs that include information not directly related to the trial in question. The new definitions include specifics as to what constitutes an unexpected or a suspected adverse drug reaction (SADR) and who can define a SADR as “serious.” The definitions also clarify the meaning behind adverse event and suspected adverse reaction by replacing it with SADR. These redefinitions are intended to aid drug sponsors and the FDA itself in gathering and analyzing data received from clinical trails. For example, more specific definitions will aid drug sponsors in differentiating if the drug in question or other preexisting conditions caused a seemingly adverse reaction. In addition, the definitions help to expedite the approval process for new drugs in the US market.

Due to the alignment of the requirements around creating new definitions and rules with international standards, it is hoped problems that at one time created conflicting standards will now be minimized. According to an FDA webpage on the new rules, “Q& A: Final Rule - New Safety Reporting Requirements for Investigational New Drug Applications (INDs),” the new rules “should help lead to consistent, harmonized reporting for globally conducted clinical trials. Safety information from clinical studies conducted outside the United States can be evaluated along with information from US clinical trials.”

More information on the final rule can be found at

GE Salmon: One Step Closer to FDA Approval

In late September, the Veterinary Medicine Advisory Committee (VMAC) of the US Food and Drug Administration (FDA) released a 180-page briefing packet describing its findings regarding genetically engineered (GE) salmon produced by AquaBounty Technologies, a company in Waltham, Massachusetts. The briefing will serve as a Freedom of Information summary in the event of the GE salmon’s approval though the FDA and includes a review of the GE salmons’ safety and effectiveness, a review of environmental impacts, and an explanation of the scientific information used in evaluating the company’s application. The committee ultimately verified in its report that the GE salmon are “as safe as food from conventional Atlantic salmon” and that the fish do not create negative environmental impacts.

If approved, the salmon will be the first GE flesh (vs vegetable) product to enter into the American food supply.

AquaAdvantage Salmon, the brand name given to the GE salmon by AquaBounty Technologies, are monosex (female), triploid (sterile) versions of Atlantic salmon that have been genetically modified with additional growth hormones derived from Chinook salmon in order to grow faster than organic Atlantic salmon. However, the GE salmon do not grow larger than their counterparts at full maturity. The VMAC also found “no biologically relevant differences” between the GE salmon and organic Atlantic salmon.

Specifically, AquaAdvantage is requesting that the FDA approve the GE salmon’s identity to be triploid hemizygous, all-female Atlantic salmon (Salmo salar); approve the claim that their GE salmon grow at least 100 g faster than their counterparts; and approve the salmon’s production as eyed-eggs in Canada that would mature in a FDA-approved facility in Panama.
Before a final decision is made, the FDA is accepting public comments on label requirements for the GE salmon until November 22, 2010—at present, the FDA has not decided whether it will be required to label the salmon as GE. The precedent in vegetables, such as soy and corn, is to not have to label them as GE.

A full copy of the briefing can be found at Comments can be submitted to the FDA regarding GE salmon at

Fish Oil Linked to Increased Risk of Colon Cancer in Mice

A recent study published in Cancer Research by researchers at Michigan State University found an increase in colon cancer in mice that had been fed high levels of docosahexaenoic acid (DHA), an omega 3 essential fatty acid (EFA) found in fish oil. Researchers were surprised by results considering the numerous studies showing EFA’s antiinflammatory effects. The mice were infected with Helicobacter hepaticus, a bacteria used to increase susceptibly to inflammatory bowel disease, which is known to increase the risk of obtaining colorectal cancer. They were then fed diets containing 0.75 percent to 6 percent levels of DHA, and results were tabulated 4 weeks later.

In humans, macronutrients such as fat have acceptable macronutrient distribution ranges (AMDRs). The current AMDR for n3 is 0.6% to 1.2% of total energy consumed. In this regard, the mice fed 6% we given almost 600% higher amounts than the AMDR. As one industry member remarked, “It is quite possible to design an experiment that will find a negative affect at a high enough dosage of any nutrient.”

According to the study, the affects of DHA on the immune system can be helpful in certain cases, but later may be proven harmful in this particular human population. Researchers admitted that dietary recommendations for fish oil are still unknown. The study specifically states that people should not avoid fish oil supplementation but rather should avoid over-supplementation, especially if omega-3 fatty acids are already present in one’s diet.

The researchers hope that this study will spearhead regulation efforts to determine a dietary reference intake for fish oil supplementation. Some members of the complementary and alternative medicine community say 1 study is hardly enough to characterize limits, especially when done only on mice. Many more studies need to be done with other diseases observed and upper limits factored in as a consideration, they say. As well, human subjects need to be used.

The study concludes, “Currently, efforts are under way to establish dietary reference intakes for EPA [eicosapentaenoic acid, another omega 3 fatty acid] and DHA due to substantial evidence supporting [the] beneficial effects of [fish oil] consumption in the prevention of common diseases such as coronary artery disease and cognitive decline. Consumer intakes of DHA and EPA continue to increase with growing [fish oil] supplement consumption . . . Studies from our group and others' advocate establishing a tolerable upper limit for [fish oil] consumption to protect certain immunocompromised sectors of the population who may be at risk for pathogen-associated enteric inflammation and gastrointestinal cancers.”

Scientists Take First Look at Nanopesticide Safety

Due to the prevalence of nanotechnology in many industries, researchers reviewed 6 issues concerning the use of nanopesticides. The study, published by the International Journal of Occupational and Environmental Health (Oct 2010), specifically looked at 1) the disclosure of nanoparticle characteristics in product formulations, 2) uncertainty factors for nanotechnology-based pesticides, 3) approaches for assessing nanopesticide exposure, 4) testing with the commercial form of nanotechnology-based pesticides, 5) initiation of a health-surveillance program, and 6) development of educational programs. Researchers of the study assume that nanopesticides could cause changes in the “bioavailability, sensitivity, dosimetry, and pharmakinetics” in products when compared with traditional pesticides, and point out areas of need for further research.

Currently, the US Environmental Protection Agency uses the Federal Insecticide, Fungicide and Rodenticide Act to evaluate existing and new pesticides. However, the Act does not specifically address the above concerns regarding nanotechnology. In a delayed response to a 2008 petition by the International Center for Technology Advancement to classify nanosilver products as pesticides, Jennifer McLain, associate director of the Antimicrobials Division of the EPA's Office of Pesticide Programs, claimed the EPA will soon require nanopesticides to be labeled “in the same way as other pesticide products,” listing ingredients as “nano-X.” No date was given as to when this regulation might take effect.

The study concluded that although the existing research on nanotechnology is “instrumental” in defining risks associated with consumer products, more research and regulation is needed to fully address the use of nanopesticides. “These measures . . . will require a coordinated effort between governmental, industry, academic, and public entities to effectively deal with a revolutionary class of novel pesticides.”

To read the entire article, visit

All contents © Copyright -2023 Integrative Medicine A Clinician's Journal. All rights reserved. Integrative Medicine A Clinician's Journal is a registered trademark.
All rights reserved. Terms and Conditions.